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Data Compensation

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DATA COMPENSATION - CANADA

The development of data to support a pesticide registration is an expensive and time-consuming process. A data owner will want to receive fair value for its investment should a follow-on applicant seek to rely on its data.

TSG has been involved in the generation of data to support pesticide applications and is well aware of not only the study costs, but also the administrative costs surrounding a data generation program. TSG has assisted data owners to develop a valuation for its data, including adjustments for inflation, risk premiums, and in-house costs. TSG has also developed estimates for studies for which documentation may not be available. For the follow-on applicant, we can develop data base cost estimates to aid in the planning of registration costs. TSG has given evidence in arbitrations regarding data requirements and data base valuation.

In Canada, the new Pest Control Act provides the statutory basis for data protection and the authority to implement regulations regarding data protection. However, these regulations have not yet been drafted. Therefore, PMRA continues to use the PSR II Trade Memorandum T-1-249 as the basis for data protection and compensation issues. TSG assists clients negotiate with PMRA through the point value system as prescribed in T-1-249. TSG can help determine the available data and develop data compensation strategies.

TSG has broad experience assisting both data owners and follow-on applications to develop value estimates of pesticide data bases in support of negotiations, arbitrations, or registration strategies.